A List of Permissible Electronic Nicotine Delivery Systems Ingredients Would Be More Effective

On January 2, 2020, the US Food and Drug Administration (FDA) released a final guidance document for industry that restricted the sale of some flavors of some e-cigarettes.¹ As of February 6, 2020, the FDA prohibited the sale in all retail locations, including online, of cartridge-based e-cigarettes that are flavored with anything other than menthol or tobacco. This guidance is intended to reverse the epidemic of e-cigarette use among youths by restricting access to vape products that appeal to youths. Although a well-crafted policy has the potential to make a big difference, this guidance is riddled with vague or missing definitions, and these omissions create unacceptable loopholes.

Any enforceable policy should have precisely and clearly crafted definitions and provisions to ensure ease in compliance and enforcement. This guidance fails to provide such clarity. First, the administration applies this restriction to only “cartridge-based ENDS products”—the vague definition includes products that have “cartridges or pods,” which are “small, enclosed units (sealed or unsealed)” that are made to be used with e-cigarettes. This definition does not specify clearly which e-cigarettes are included and which are not, and this presents enforcement challenges. Although the FDA clarifies in the guidance that it does not intend to restrict tank systems, the definition does not clearly exempt such systems.

A second shortcoming of this guidance is that it leaves open a major loophole by omitting disposable products from the definition of cartridge-based ENDS products. Although Juul has commanded a large market share and should be regulated, it is a mistake to give a free pass to disposable products that have the same appeal of Juul and would continue to be sold in candy and fruit flavors especially appealing to youths. The guidance should be aimed at capturing all products that are most appealing to youths—including products that are disposable and those that have refillable cartridges.

The guidance also fails to give meaning to what a “flavor” is or how a prohibited flavor can be identified. More than 100 local jurisdictions in the United States have passed flavor restrictions, and the FDA should learn from those experiences. Most importantly, flavor restrictions cannot be based on what e-cigarette companies write on their package labels. Tobacco companies are nimble, and if given the opportunity through a vague policy, manufacturers will simply change the name of their product to no longer indicate that there is a flavor, while leaving the ingredients of the product untouched. The current policy would allow Juul to simply tweak the wording of their “mint”-flavored product so that it becomes “fresh menthol” (Figure A, available as a supplement to the online version of this artice at http://www.ajph.org). If Juul made this change, one of the most popular flavors for youths could remain on the market unrestricted.

The issues that we raise require urgent action. Past 30-day use of e-cigarettes among adolescents has skyrocketed upward, from 1.5% in 2011 to 20.8% in 2018.² Although in September 2018 the FDA stated that they would not tolerate a worsening youth epidemic, e-cigarette use increased again to 27.5% in 2019.³ The FDA must strengthen this guidance to protect youths and begin to reverse the e-cigarette epidemic by reining in unscrupulous e-cigarette manufacturers. For a comprehensive and long-term approach, the FDA should propose a rule that prohibits flavors in all tobacco products, including menthol. Because of the difficulty in establishing, maintaining, and verifying a prohibited list, perhaps a more effective standard would be for the FDA to establish a list of ingredients that are permissible in tobacco products, which would not include any flavors. The FDA should also consider the harms that flavors cause when evaluating whether products should remain on the market through its premarket review authority.